Study Details

Study Purpose

To assess dryness and scalp itching for sensitive scalp of only shampoo in one group and shampoo and conditioner in another group of participants. This study will evaluate the benefits of two regimens for sensitive scalp, in terms of moisturizing and barrier improvement through the utilization of expert grading, participant questionnaires and non-invasive instrumental measures. Approximately 75 participants will participate in the conditioning phase of the study and of these, approximately 60 healthy males and females, ages 18 through 65 having Fitzpatrick I-VI (scale I to VI will depend on your skin tone as after winter, during the first 45 – 60 minutes of sun exposure without sunscreen), will participate in the product application phase of the study. Note: non-invasive means no introduction of any instrument into the body. ”Instrumentation” or “instrument” means readings will be taken by using different electronic devices.

Study Duration

Total 5 Visits

Study Schedule

General Screening

N/A

Medical Screening

N/A

Study Visit(s)

Visit 1 (Approx. 1 hour) [26/NOV/22]
Informed Consent, Medical history review, inclusion/exclusion questions, Sensitive Scalp Questionnaire, conditioning product distribution and instructions

Visit 2 (Approx. 3 hours) [03/DEC/22]
This visit will take approximately 3 hours. At this visit, you will fill out questionnaires before the acclimation, and an evaluator will examine your scalp to determine whether you will qualify for the study. You will sit in an environmentally controlled room (64.4°F-68°F (18°C-20°C) and 25%-40% relative humidity) with your scalp exposed for at least 25 minutes. If you qualify, you will be assigned a unique 4-digit id for the product application and assessment phase. Immediately after visual evaluations, instrumental readings will be taken from each test site, to measure moisture on the scalp (TEWL Measurements). At least three readings per test site will be collected. The instruments do not penetrate the skin; they rest on the surface of the skin and are painless. After these readings, the first application of test product(s) will occur on site by study staff. Following application you will be reminded of instructions and given an appointment time for your next visit the following day.

Visit 3 (Approx. 1 hour) [04/DEC/22]
This visit will be 24 hours after product application. You will have a visual assessment and instrumentation readings taken after at least 25 minutes of sitting in an environmentally controlled room and you will answer a questionnaire. You will be provided with products for use at-home as well as a diary and a set of instructions to follow during the product application and assessment phase.

Visit 4 (Approx. 1 hour) [10/DEC/22]
You are required to bring back your test product to this visit. This visit will be considered as Week 1 after product application. You will have a visual assessment and instrumentation readings taken after at least 25 minutes of sitting in an environmentally controlled room. . You will also be answering questionnaires and your daily diaries will be reviewed. You will be reminded of instructions to follow during the product applicaiton and assessment phase.

Visit 5 (Approx. 1 hour) [17/DEC/22]
You are required to bring back your test product to this visit. This visit will be considered as Week 2 after product application. You will have a visual assessment and instrumentation readings taken after at least 25 minutes of sitting in an environmentally controlled room. . You will also be answering questionnaires and your daily diaries and the products will be reviewed and collected.

Follow-Up Visit(s)

N/A

Other Notes

Bring valid ID